BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCAS CPR CHEST COMPRESSION SYSTEM

    MDR report key: 4001530 · Received July 1, 2014

    Report

    Report Number
    3005445717-2014-00002
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    December 9, 2011
    Report Date
    June 27, 2014
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL, INC., AN IMPORTER/DISTRIBUTOR FOR JOLIFE AB, EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE COMPRESSION MODULE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL, INC, FURTHER EVALUATED THE REMOVED COMPRESSION MODULE ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED WINDING WITHIN THE COMPRESSION MODULE MOTOR. THIS REPORT HAS BEEN PREVIOUSLY REPORTED BY PHYSIO-CONTROL, INC. UNDER MANUFACTURER REPORT # 3015876-2012-00148.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT, DURING PT USE, THE LUCAS 2 DEVICE DID NOT PROVIDE ADEQUATE COMPRESSION FORCE DURING THE CPR PROCESS. THE PT'S BLOOD PRESSURE WAS BEING MONITORED DURING THE MECHANICAL CHEST COMPRESSION PROCESS, AND IT WAS OBSERVED TO BE LOW (AROUND 30MMHG) AND THE END USER REMOVED THE LUCAS 2 DEVICE AND CONTINUED WITH MANUAL CHEST COMPRESSIONS. THE PT DID NOT SURVIVE. THE END USER REPORTED THAT THE PT'S OUTCOME WAS INDEPENDENT FROM THE REPORTED DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385398 LUCAS CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1